A Study to Investigate the Effect of a Meal At 6pm the Day Before the Colonoscopy on the Bowel Cl… (NCT06651398) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study to Investigate the Effect of a Meal At 6pm the Day Before the Colonoscopy on the Bowel Cleansing with Plenvu
Belgium525 participantsStarted 2023-02-14
Plain-language summary
Bowel cleansing prior to colonoscopy is crucial to be able to perform a high-quality examination. Therefore maximum efforts are made to achieve optimal bowel cleansing including diet restriction and refraining from day-before dinner. However, the effect of this interdiction is currently not clear. On the other hand, patient compliance and experience with the entire procedure is important, especially for follow-up colonoscopies. Strict diets may interfere with this as an additional burden on the patient. In this study we want to assess whether a more lenient diet influences the quality of bowel preparation and whether it improves patient's experience.
Who can participate
Age range
40 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient referred for diagnostic colonoscopy
* Age between 40 and 85 years old
* Ability of normal oral ingestion
* Able to give informed consent by the patient or the legal representative
Exclusion Criteria:
* Participant has a history of (partial) colectomy, excluding appendectomy
* Inability of oral ingestion
* Chronic severe constipation, defined as the need for daily laxative use of any kind or the need to use laxatives to obtain defaecation.
* Uncontrolled coagulopathy
* Pregnancy
* Premenopausal women not adhering to any contraceptive method
* Inflammatory bowel disease
* Lynch syndrome
* Familial adenomatosis polyposis syndrome
* Serrated polyposis syndrome
* hypersensitivity to the active substances of PLENVU as listed in the SmPC section 6.1
* gastrointestinal obstruction or perforation
* ileus
* gastric emptying disorders (e.g. gastroparesis, gastric retention, etc.)
* phenylketonuria (due to the presence of aspartame in PLENVU)
* glucose-6-phosphate dehydrogenase deficiency (due to the presence of ascorbate in PLENVU)
* toxic megacolon
* Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
* Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients with an adequate bowel preparation (BBPS ≥6, and no segmental subscore ≤1)